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US FDA 1572 - completion for ex-US sites



  • Anon
    30/01/2020 14:31
    Is anyone aware of a regulation / GUI / Reflection Paper that suggests ex-US sites are not required to sign the US FDA 1572 . Thank you.
  • Colin Wilsher
    30/01/2020 15:23
    Yes. The FDA Q& A document on 1572. Google it. Also there are lots of discussion here on RQA discussion forum on this topic
  • Colin Wilsher
    30/01/2020 15:30
    Yes. The FDA Q& A document on 1572. Google it. Also there are lots of discussion here on RQA discussion forum on this topic
  • Anon
    30/01/2020 17:30
    Thank you, Colin. Will take a look right away.
  • Aldwin Aldana
    27/02/2020 18:23
    1. Danish Medical Agency website, “Clinical trials under US legislation” Questions & Answers published 02 October 2017: https://laegemiddelstyrelsen.dk/en/licensing/clinical-trials/ gcp-inspection/clinical-trials-under-us-legislation/ 2. ZLG website, Vote summary V05005 “Handling of FDA 1572 form in Germany” of 27 September 2017 (officially published on ZLG website on 29 Jan 2018): https:// www.zlg.de/index.php?eID=tx_nawsecuredl&u=0&file=fileadmin/downloads/AM/QS/V05005.pdf&hash=a4aa55d4542a4b641237886a8586ca9d42474aee 3. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Inspection of Good Clinical Practice. Use of the 1572 form in Spain(Published on the AEMPS website on April 24, 2019): https://www.aemps.gob.es/industria-farmaceutica/buena-practica-clinica/?lang=en#forma1572
  • Aldwin Aldana
    27/02/2020 18:52
    The European Federation of Pharmaceutical Industries and Associations (EFPIA) Clinical Development Expert Group (CDEG) has also published its position paper on the use of Form FDA 1572 for clinical trials performed outside the USA on 14 January 2020: https://www.efpia.eu/media/413440/efpia-cdeg-position-paper-on-the-use-of-form-fda-1572-for-clinical-trials-performed-outside-the-usa.pdf
  • Colin Wilsher
    27/02/2020 19:51
    Fantastic information. Thanks. In fact the FDA has been sending messages since 2003 stating that it is easier for them if non-US sites are outside of the IND. And its cheaper and less hassle for the sponsor >> PS> Did you know that that the RQA GCP Committee is looking for more volunteers?
  • Aldwin Aldana
    04/03/2020 16:27
    I would like to learn more about the volunteer opportunities.
  • Colin Wilsher
    04/03/2020 16:34
    Go on RQA website and contact
  • Alice
    14/12/2020 09:57
    Where I can find the a full list of EU Competent Authority who are refusing to allow investigators at sites in their country to sign Form FDA 1572? The list on the EFPIA CDEG position paper is not complete: " (e.g. in Belgium, Germany, Denmark, Sweden, Norway)"
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